The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.

Eligibility

Ages Eligible for Study:

18 Years to 45 Years

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Subjects may be eligible to participate if they:

Are males with HIV infection with a positive HIV antibody test

Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)

Have CD4+ cell counts ≥ 50 cells/ml

Are 18-45 years of age, inclusive

Have a body mass index (BMI) ≥ 18 kg/m2

Are antiretroviral nucleoside reverse transcriptase inhibitor-naive

Have read and understand the informed consent,and is able and willing to comply with study procedures

Exclusion Criteria

Subjects may not participate if they:

Have clinically significant ECG abnormalities

Have clinically significant abnormalities in any safety laboratory parameters

Have an ALT value ≥ 3xUNL

Have previously participated in this trial

Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug

Have a history of chronic alcohol or drug abuse within the last 6 months

Have a positive urine drug screening

Have a positive alcohol breath test

Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject’s ability to participate in this trial

Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.